Ramosetron versus Palonosetron in Combination with Aprepitant and Dexamethasone for the Control of Highly-Emetogenic Chemotherapy-Induced Nausea and Vomiting
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Purpose The purpose of this study was to compare ramosetron (RAM), aprepitant (APR), and dexamethasone (DEX) [RAD] with palonosetron (PAL), APR, and DEX [PAD] in controlling highlyemetogenic chemotherapy (HEC)–induced nausea and vomiting. Materials and Methods Patients were randomly assigned (1:1) to receive RAD or PAD:RAM (0.3 mg intravenously) or PAL (0.25 mg intravenously) D1, combined with APR (125 mg orally, D1 and 80 mg orally, D2-3) and DEX (12 mg orally or intravenously, D1 and 8 mg orally, D2-4). Patients were stratified by sex, cisplatin-based chemotherapy, and administration schedule. The primary endpoint was overall complete response (CR), defined as no emesis and no rescue regimen during 5 days of HEC. Secondary endpoints were overall complete protection (CP; CR+nausea score < 25 mm) and total control (TC; CR+nausea score < 5 mm). Quality of life was assessed by Functional Living Index Emesis (FLIE) questionnaire on D0 and D6. Results A total of 279 patients receiving RAD (n=137) or PAD (n=142) were evaluated. Overall CR rates in RAD and PAD recipients were 81.8% and 79.6% (risk difference [RD], 2.2%; 95% confidence interval [CI], !7.1 to 11.4), respectively. Overall CP and TC rates for RAD and PAD were 56.2% and 58.5% (RD, !2.3%; 95% CI, !13.9 to 9.4) and 47.5% vs. 43.7% (RD, 3.8%; 95% CI, !7.9 to 15.5), respectively. FLIE total score " 108 (no impact on daily life) was comparable between RAD and PAD (73.9% vs. 73.4%, respectively). Adverse events were similar between the two groups. Conclusion In all aspects of efficacy, safety and quality of life, RAD is non-inferior to PAD for the control of chemotherapy-induced nausea and vomiting in cancer patients receiving HEC.
Abstract
Purpose The purpose of this study was to compare ramosetron (RAM), aprepitant (APR), and dexamethasone (DEX) [RAD] with palonosetron (PAL), APR, and DEX [PAD] in controlling highlyemetogenic chemotherapy (HEC)–induced nausea and vomiting. Materials and Methods Patients were randomly assigned (1:1) to receive RAD or PAD:RAM (0.3 mg intravenously) or PAL (0.25 mg intravenously) D1, combined with APR (125 mg orally, D1 and 80 mg orally, D2-3) and DEX (12 mg orally or intravenously, D1 and 8 mg orally, D2-4). Patients were stratified by sex, cisplatin-based chemotherapy, and administration schedule. The primary endpoint was overall complete response (CR), defined as no emesis and no rescue regimen during 5 days of HEC. Secondary endpoints were overall complete protection (CP; CR+nausea score < 25 mm) and total control (TC; CR+nausea score < 5 mm). Quality of life was assessed by Functional Living Index Emesis (FLIE) questionnaire on D0 and D6. Results A total of 279 patients receiving RAD (n=137) or PAD (n=142) were evaluated. Overall CR rates in RAD and PAD recipients were 81.8% and 79.6% (risk difference [RD], 2.2%; 95% confidence interval [CI], !7.1 to 11.4), respectively. Overall CP and TC rates for RAD and PAD were 56.2% and 58.5% (RD, !2.3%; 95% CI, !13.9 to 9.4) and 47.5% vs. 43.7% (RD, 3.8%; 95% CI, !7.9 to 15.5), respectively. FLIE total score " 108 (no impact on daily life) was comparable between RAD and PAD (73.9% vs. 73.4%, respectively). Adverse events were similar between the two groups. Conclusion In all aspects of efficacy, safety and quality of life, RAD is non-inferior to PAD for the control of chemotherapy-induced nausea and vomiting in cancer patients receiving HEC.
참고문헌 (22)
- Lindley C, "Perception of chemotherapy side effects cancer versus noncancer patients", Cancer Pract, 7, pp.59~65 (1999)
- Passik SD, "The changeable nature of patients' fears regarding chemotherapy : implications for palliative care", J Pain Symptom Manage, 21, pp.113~120 (2001)
- Fernandez-Ortega P, "Chemotherapy-induced nausea and vomiting in clinical practice : impact on patients' quality of life", Support Care Cancer, 20, pp.3141~3148 (2012)
- Hesketh PJ, "The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting : a multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin--the Aprepitant Protocol 052 Study Group", J Clin Oncol, 21, pp.4112~4119 (2003)
- Grunberg SM, "Palonosetron : a unique 5-HT3-receptor antagonist for the prevention of chemotherapyinduced emesis", Expert Opin Pharmacother, 4, pp.2297~2303 (2003)
- Eisenberg P, "Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor antagonist : results of a phase III, single-dose trial versus dolasetron", Cancer, 98, pp.2473~2482 (2003)
- Gralla R, "Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy : results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron", Ann Oncol, 14, pp.1570~1577 (2003)
- "Antiemesis (version 1.2020)" (2020)[URL]
- Rabasseda X, "Ramosetron, a 5-HT3 receptor antagonist for the control of nausea and vomiting", Drugs Today(Barc), 38, pp.75~89 (2002)
- 김진수, "Multicenter nonrandomized trial of ramosetron versus palonosetron in controlling chemotherapy-induced nausea and vomiting for colorectal cancer", Annals of Surgical Treatment and Research, 87(1), pp.9~13 (2014), 대한외과학회
- Martin AR, "Assessing the impact of chemotherapy-induced nausea and vomiting on patients' daily lives : a modified version of the Functional Living Index-Emesis(FLIE)with 5-day recall", Support Care Cancer, 11, pp.522~527 (2003)
- Rhodes VA, "Criteria for assessment of nausea, vomiting, and retching", Oncol Nurs Forum, 24(7 Suppl), pp.13~19 (1997)
- "National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)" (2010)[URL]
- Suzuki K, "Randomized, double-blind, phase III trial of palonosetron versus granisetron in the triplet regimen for preventing chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy : TRIPLE study", Ann Oncol, 27, pp.1601~1606 (2016)
- Navari RM, "Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting : a randomized phase III trial", J Support Oncol, 9, pp.188~195 (2011)
- Hesketh PJ, "Efficacy and safety of NEPA, an oral combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy : a randomized dose-ranging pivotal study", Ann Oncol, 25, pp.1340~1346 (2014)
- Roila F, "Aprepitant versus metoclopramide, both combined with dexamethasone, for the prevention of cisplatin-induced delayed emesis : a randomized, double-blind study", Ann Oncol, 26, pp.1248~1253 (2015)
- Gralla RJ, "A phase III study evaluating the safety and efficacy of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting over repeated cycles of chemotherapy", Ann Oncol, 25, pp.1333~1339 (2014)
- Wu F, "Phase III randomized trial of palonosetron and dexamethasone with or without aprepitant to prevent nausea and vomiting induced by full-dose single-day cisplatin-based chemotherapy in lung cancer", Clin Lung Cancer, 19, pp.e913~e918 (2018)
- Zhang L, "A randomized phase III study evaluating the efficacy of single-dose NEPA, a fixed antiemetic combination of netupitant and palonosetron, versus an aprepitant regimen for prevention of chemotherapy-induced nausea and vomiting(CINV)in patients receiving highly emetogenic chemotherapy(HEC)", Ann Oncol, 29, pp.452~458 (2018)
- Kim HJ, "Ramosetron versus ondansetron in combination with aprepitant and dexamethasone for the prevention of highly emetogenic chemotherapy-induced nausea and vomiting : a multicenter, randomized phase III trial, KCSG PC10-21", Oncologist, 20, pp.1440~1447 (2015)
- Hirata T, "Evaluation of the pharmacological profile of ramosetron, a novel therapeutic agent for irritable bowel syndrome", J Pharmacol Sci, 104, pp.263~273 (2007)